APPROACH-J Study: Design, Rationale, and Baseline Data of the Affirmation Primary Prevention with Pravastatin in Reduction of Occlusive Atherosclerotic Complications in Hypercholesterolemia-Japan Study

Abstract

We investigated the relationship between the lipid levels achieved in a high-risk group of patients undergoing primary prevention with pravastatin and the incidence of cardiovascular disease, and moreover the influence of lifestyle compliance on lipid control. In the APPROACH-J study, 6,229 patients who were treated with pravastatin were enrolled, and will be followed for two years. The subjects are men aged 20 years or older and women aged 55 years or older (or postmenopausal women) receiving primary prevention, who are categorized as high-risk patients with 3 or more major risk factors other than the LDL-C level according to the Japan Atherosclerosis Society guideline. Achieved LDL-C levels will be used to categorize the subjects into four quartiles for this analysis, and the maximum contrast method based on the Cox proportional hazards model will be used to investigate the relations between achieved LDL-C and the incidence of vascular event. Multiple linear regression analysis will be used to investigate the relations between adherence scores and achieved lipid level. In 5,871 patients (58.5% women) who were eligible for analysis, the mean age was 66.4 years. The mean LDL-C at baseline was 135.9 mg/dL. The risk factors other than LDL-C were aging in 95.4%, diabetes in 76.9%, hypertension in 72.2%, a family history of coronary artery disease (CAD) in 20.9%, smoking in 20.0%, and low high-density lipoprotein cholesterol in 11.1%. The results of this study are expected to confirm the validity of the target LDL-C level for high-risk patients receiving primary prevention and the importance of improving adherence for primary prevention.